Abstract

Fueled by massive settlements and concerns about pharmaceutical company influence over medical practice, the fight over off-label promotion has become a rancorous one with little middle ground. For some, off-label restrictions are both bad law and bad medicine, violating the First Amendment while denying physicians access to crucial information. For others, the battle pits the very soul of the FDA against the excesses of a profit-driven marketplace. Far from ameliorating concerns over manufacturer influence, the New Model proposed by Bennett et al. would exacerbate them. The Model would limit FDA authority to core communications proposing immediate commercial transactions, giving manufacturers unfettered discretion over scientific exchanges and nearly free rein over truthful quasi-commercial communications. Most problematically, the New Model relies on the longstanding assumption that truly educational and scientific activities can be distinguished from simple product promotion – a dichotomy that exists not only in federal law and professional association codes, but also underlies the jurisdiction of the federal agencies overseeing the pharmaceutical sector. Experience invites skepticism that these activities can be cleanly separated, suggesting that the New Model may simply perpetuate abusive behaviors without offering concomitant benefits to physicians or patients.

Krause, Joan H., Off-Label Drug Promotion and the Ephemeral Line between Marketing and Education (November 19, 2015). Journal of Law and the Biosciences, 2015, DOI: 10.1093/jlb/lsv052; UNC Legal Studies Research Paper No. 2714501. Available at SSRN: https://ssrn.com/abstract=2714501